Director, Biostatistics — Bayesian & Adaptive Trials

Hemab Therapeutics; København; On-site; DKK 800,000 - 1,000,000; Full time

Job summary

Hemab Therapeutics, Copenhagen, Denmark, is hiring a Director of Biostatistics to shape statistical strategy for a leading rare bleeding disorder program. You will lead trial design, analysis plans, and regulatory documentation while guiding a small, high‑impact team.

You will collaborate with clinical, regulatory, and executive teams to drive scientifically rigorous trials, leverage Bayesian methods, and ensure regulatory readiness.

Qualifications

• PhD in Statistics/Biostatistics with 8+ years in pharma/biotech, or Master's with 12+ years.
• Experience in early to late-stage development; NDA/BLA submission preferred.
• Ability to influence development strategy and executive decisions.
• Excellent communication to explain complex stats to non-statisticians.
• Experience with adaptive trial designs, Bayesian methods and simulations.
• Strong project management across multiple programs.
• Direct experience with rare diseases or hematology trials is desirable.

Responsibilities

• Lead statistical input for clinical development plans, protocol design, endpoints, data analysis and interpretation.
• Develop innovative trial designs including adaptive and Bayesian approaches to maximize learning from limited patient populations.
• Author SAPs and statistical sections of regulatory documents; perform analyses to inform decisions.
• Provide strategic statistical guidance for go/no-go decisions and portfolio prioritization.
• Prepare statistical components for regulatory submissions (INDs, NDAs/BLAs, CSRs).
• Oversee CRO statistical deliverables and vendor relationships.
• Lead cross-functional collaboration with Clinical Research, Clinical Pharmacology, Clinical Operations, Data Management, Regulatory Affairs, and Medical Affairs.
• Mentor/manage junior statistician(s).

Skills

Statistical leadership

Clinical trial design

Bayesian methods

Regulatory understanding

Communication skills

Education

PhD in Statistics/Biostatistics

Master's degree in Statistics/Biostatistics

Job description

Hemab Therapeutics, Copenhagen, Denmark, is hiring a Director of Biostatistics to shape statistical strategy for a leading rare bleeding disorder program. You will lead trial design, analysis plans, and regulatory documentation while guiding a small, high‑impact team.

You will collaborate with clinical, regulatory, and executive teams to drive scientifically rigorous trials, leverage Bayesian methods, and ensure regulatory readiness.